# Evaluating the role of allergen dose and duration in the safety and efficacy of multi-allergen oral immunotherapy with Omalizumab

> **NIH NIH UM1** · STANFORD UNIVERSITY · 2020 · $235,000

## Abstract

Project Summary
The incidence and prevalence of food allergies is rising in children and adults, with peanut and tree nut being
the most common food allergens. Current oral immunotherapy (OIT) protocols to desensitize patients to culprit
allergens are associated with side effects that affect compliance and efficacy of OIT. More than 30% of patients
with food allergies are allergic to more than one food. Safer OIT protocols that minimize side effects while
improving challenge thresholds to multiple allergens are needed to be able to address this food allergy
epidemic. To address these challenges, we propose a multi-site phase 2 clinical study in children and adults
with peanut and tree nut allergies, using Omalizumab. Omalizumab is an anti-IgE monoclonal antibody which
decreases free IgE in the blood and on mast cells and basophils, to minimize allergic inflammation. We
hypothesize that omalizumab pre-treatment followed by low dose maintenance therapy of multi-food OIT will
minimize side effects while increasing the challenge thresholds for multi-food allergic patients. Our approach is
to design a randomized, controlled Phase 2 study with two arms: Omalizumab plus low dose multi-food OIT
versus Omalizumab plus high dose multi-food OIT to contribute to the overall CoFAR objectives of improving
safety and efficacy of OIT protocols. In implementing this study, we will create a comprehensive dataset of
clinical outcomes from multiple sites within CoFAR and patient samples to understand mechanisms of treatment
success. Our specific aims are 1) Test whether treatment of children and adults with Omalizumab and food OIT
to peanut and walnut increases the ability to pass a food challenge to 2g of at least 2 allergens: peanut and
walnut; 2) Determine whether treatment of children and adults in low vs high maintenance arms of multi food
OIT with omalizumab is safer; and 3) Evaluate to what degree laboratory and clinical testing methods (i.e.
endotypes and phenotypes of food allergic patients) are associated with safety and efficacy outcomes (in
Specific Aims 1 and 2) in low dose versus high dose maintenance groups. If the aims of our proposal are met,
we will determine the optimal maintenance dose protocol for desensitization to multiple foods with omalizumab
that causes minimal side effects with optimal success rates.

## Key facts

- **NIH application ID:** 9880384
- **Project number:** 5UM1AI130839-04
- **Recipient organization:** STANFORD UNIVERSITY
- **Principal Investigator:** R. Sharon Chinthrajah
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $235,000
- **Award type:** 5
- **Project period:** 2017-03-01 → 2024-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9880384

## Citation

> US National Institutes of Health, RePORTER application 9880384, Evaluating the role of allergen dose and duration in the safety and efficacy of multi-allergen oral immunotherapy with Omalizumab (5UM1AI130839-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9880384. Licensed CC0.

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